Antwerp, Belgium
NCT Number: NCT02870400
A Study to Examine the Safety and Tolerability of Single Ascending Doses of REGN2477
The primary objective of the study is to assess the safety and tolerability of single ascending doses of REGN2477 in healthy women not of childbearing potential.
Looking for future studies?
Notify MeKey information
Conditions
Age range
18 year–65 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 1
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Healthy women not of childbearing potential between 18 and 65 years of age, with no significant health issues or clinically significant abnormal laboratory findings
- A body mass index (BMI) between 18 to 30 kg/m2, inclusive
- Provide a signed informed consent
Exclusion criteria
- Significant illness or history of significant illness
- Clinically significant abnormal CBC, clinical chemistry, and urine analysis at screening
- Current smoker or former smoker who has stopped smoking within 3 months prior to screening
- Positive urine drug test results during screening, or history of drug or alcohol abuse
- Donation or loss of, blood within 8 weeks prior to screening, or plasma up to 14 days prior to screening
- History of diabetes
- Abnormal blood pressure (BP)
- History of gynecological disorders or malignancies; history of breast malignancies; or history of benign gynecological or breast lesions that require medical treatment or follow up
- Reduced renal function
- Known history of chronic hepatitis or HIV
- Clinically significant ECG abnormalities
- Participation in any clinical research study within 30 days, or 5 halflives, of the study drug, whichever is greater, or for longer periods per regional requirements, prior to the screening visit
- Exposure to any biological drugs within 3 months of the screening visit (the name of the drug and duration of previous exposure will be recorded). Vaccination within 4 weeks of screening visit.
- History of hypersensitivity reactions to vaccines or other biologics
- History of hypersensitivity to doxycycline or other tetracycline antibiotics
- History of osteoporosis requiring osteoporosis treatments such as PTH, bisphosphonates, and denosumab
- Subject using hormone replacement therapy or thyroid replacement therapy will be excluded, unless they have been on stable doses of such therapy for at least 6 months and will remain on the same stable dose through the duration of the trial
- Use of systemic glucocorticoids, including oral glucocorticoids, for more than 10 days, within 3 months prior to screening.
Treatment and study plan
REGN2477
DrugParticipants will receive ascending doses of REGN2477
Placebo
DrugParticipants will receive matching placebo
Primary outcomes
-
Treatment emergent adverse events (TEAEs) through day 113 in participants treated with REGN2477
Time frame: Day 1 to Day 113
Secondary outcomes
-
Pharmacokinetic profile of REGN2477, assessed via serum concentrations of REGN2477 over time
Time frame: Day 1 to Day 113
-
Immunogenicity of REGN2477, as determined by the presence or absence of Anti-drug antibody (ADA) to REGN2477 over time
Time frame: Day 1 to Day 113
Sponsors and collaborators
Lead sponsor
Regeneron Pharmaceuticals
Industry
Registry information
Official study title
A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Effects of Intravenously and Subcutaneously Administered REGN2477 in Healthy Women Not of Childbearing Potential
Important dates
- Study start
- 2016
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Aug 17, 2016
- Registry last updated
- Feb 20, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Spirulina Oral Supplement for Enhancing Host Resilience to Virus Infection
NCT05447078
Healthy Volunteers, Infections
Jackson, Mississippi, United States
View Trial DetailsThe Primary Purpose of This Study is to Determine if Biotin, Vitamin B7 is an Effective Way to Label Platelets in Survival and Recovery Studies.
NCT07513532
Healthy Volunteers
Seattle, Washington, United States
View Trial DetailsA Phase 1 Study of Budoprutug (TNT119) Subcutaneous and Intravenous Injections in Normal Healthy Volunteers
NCT07090655
Healthy Volunteers
Brisbane, Australia
View Trial DetailsStudy of the Safety of a Particular Herpes Vaccine in Adults With or Without Herpes Infection
NCT01915212
Communicable Diseases, DNA Virus Infections
Bethesda, Maryland, United States
View Trial Details